Atopic dermatitis is chronic or recurrent dermatitis caused by complicated etiology including environmental and hereditary factors. It has diverse symptoms such as pruritus, erythema, papule, edema, oozing, crust, and lichenification. To increase treatment efficiency in atopic dermatitis, not only oral administration but external application of medication such as cosmetics and ointment is also essential. However, external medication has limitation that the absorption of bioactive substances is remarkably disturbed by the skin barrier. To overcome this, transdermal drug delivery system has been briskly studied. Microneedle patch, which is one of transdermal drug delivery system, is a medical device promoting absorption of medication through making small channels penetrating the skin barrier. Taking advantage of microneedle patch, there are many attempts to apply it for the treatment of various diseases. Thus, this study aims to evaluate the efficacy and safety of biodegradable microneedle patch for ameliorating dry skin in atopic dermatitis patients. For atopic dermatitis patients with dry skin, we are going to compare the combination treatment of topical medication and microneedle patch and the single treatment of topical medication.

Treatment

Microneedle patch used in this study is a medical device made up of biodegradable hyaluronic acid microneedles on the hydrocolloid substrate film. If the patch is attached after applying topical medication on the skin, microneedles helps absorbing medicinal ingredients through stimulating stratum corneum. In this study, we are going to recruit 20 atopic dermatitis patients with dry skin as the participants and select 2 similar skin lesion per participant. Through randomization, 2 skin lesions of a participant are divided into the experimental group and the control group. To the control group, only topical medication is applied for 2 weeks. To the experimental group, microneedle patch is additionally attached after applying topical medication for 2 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

For 2 weeks, apply aroma cream to the skin of control area once every day before sleep.

Arm Label

Target Number of Participant

Arm Type

Arm Description

For 2 weeks, attach the biodegradable microneedle patch on the skin applied aroma cream once every day before sleep. Before attachment, clean the experimental area of the skin. For the area where microneedle patch be attached, any other topical medications such as lotion or cream should not be applied with aroma cream at the same time. The patch should be vertically attached on the experimental area and microneedle area should not be touched until attached. After attachment, press the patch evenly. On the next day after attachment, remove the patch after waking up in the morning.

Gender

Age

Description

(1) Male and female patients aged 19-60 at the screening visit.
(2) Atopic dermatitis patients diagnosed by Hanifin and Rajka criteria and have dry skin. Atopic dermatitis can be diagnosed if the patient has more than 3 of 4 major symptoms and 3 of 23 minor symptoms in the Hanifin and Rajka criteria.
(3) Patients who have 2 similar dry areas at the limbs in order to compare the efficacy of solitary local external preparation application with combination therapy of local application and soluble microneedle patch.
(4) Patients who submitted written consent voluntarily.

(1) Patients who were taking intensive medication such as antihistamines or steroids.
(2) Patients who used oral antihistamines, oral antibiotics, oral or topical steroids, systemic photochemotherapy, or other immunosuppressants within 4 weeks before this study begins.
(3) Patients having systemic infection or taking systemic antibiotic therapy.
(4) Patients having other severe skin diseases except atopic dermatitis.
(5) Patients taking interferon medication.
(6) Liver patients including cirrhosis or liver cancer.
(7) Kidney patients including acute or chronic renal failure, or nephrotic syndrome.
(8) Severe acute cardiovascular patients including heart failure, myocardial infarction, or stroke.
(9) Patients who took antipsychotics within 3 months before screening.
(10) Patient who are sensitive to natural products.
(11) Patients who have an allergy to adhesives. 
(12) Pregnant or nursing women.
(13) Severe oozing or maceration.
(14) Others who investigators decided inadequate.

Change in skin lesion comparing photos on the 2nd week with the baseline

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Change in L-SCORAD index on the 2nd week from the baseline

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Change in investigator's global assessment(IGA) score on the 2nd week from the baseline

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Change in total SCORAD index on the 2nd week from the baseline

Visit 1, 2

Change in DLQI score on the 2nd week from the baseline

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Change in VAS score for pruritus on the 2nd week from the baseline

Visit 1, Visit 2

Change in VAS score for skin dryness on the 2nd week from the baseline

Visit 1, Visit 2

Change in skin hydration on the 2nd week from the baseline

Visit 1, Visit 2

Change in transepidermal water loss(TEWL) on the 2nd week from the baseline

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Change in participant's satisfaction on the 2nd week from the baseline

Visit 1, Visit 2

1. The biodegradable hyaluronic acid microneedle (BHMN) patch combination therapy significantly improved the L-SCORAD index compared with topical medication alone. 
2. For VAS score, the BHMN patch combination therapy significantly improved the VAS for skin dryness compared with topical medication alone. However, the BHMN patch combination therapy did not show superiority over the control treatment in the VAS for pruritus.
3. The BHMN patch combination therapy significantly increased skin hydration compared with the control treatment.
4. In addition, the SCORAD index and DLQI also significantly improved, which reflects the improvement in QoL of the participants.
5. Considering that there were no adverse events during the trial, the BHMN patch can be determined to be a safe medical device.